See American Psychiatric Association Request for Assistance
Dear Commissioner Makary,
On behalf of the American Psychiatric Association (APA), the largest medical specialty society representing more than 39,200 physicians who specialize in the treatment of mental illnesses, including substance use disorders, we appreciate the agency’s attention to maternal mental health. However, we are alarmed and concerned by the misinterpretations and unbalanced viewpoints shared by several of the panelists for the Expert Panel on Selective Serotonin Reuptake Inhibitors (SSRIs) and Pregnancy panel on July 21st. This propagation of biased interpretations at a time when suicide is a leading cause of maternal death within the first postpartum year could seriously hinder maternal mental health care. The inaccurate interpretation of data, and the use of opinion, rather than the years of research on antidepressant medications, will exacerbate stigma and deter pregnant individuals from seeking necessary care.
Mood and anxiety disorders occur in one in five pregnancies, yet they remain largely undiagnosed, untreated, or undertreated. Suicide is a major cause of mortality for women in the perinatal period, accounting for 5–20% of maternal deaths.1 In 2023, APA released a perinatal mental health toolkit that includes a white paper and factsheets for patients and providers to ensure that informed and transparent care can be provided to individuals at this stage in life.2 The results of the literature review for the white paper show an association between unmanaged perinatal mental health problems and adverse outcomes for pregnant individuals and fetus/child, including increased morbidity and mortality.3 Research shows the risk to the mother and child from untreated mental health disorders may lead to harmful outcomes.4 This underscores the need for widespread and standardized screening practices with validated tools such as the Edinburgh Postnatal Depression Scale (EPDS), the Patient Health Questionnaire (PHQ-9), and the Generalized Anxiety Disorder-7 (GAD-7), and a greater commitment by the field to developing and implementing perinatal specific prevention and treatment initiatives.
The overall evidence suggests that individuals can and should take SSRIs prior to or during pregnancy, when they are clinically indicated for treatment. Moreover, recent meta-analyses have found no association between prenatal SSRI exposure and overall risk of birth defects.5 The analysis goes on to say that some concerns with specific SSRIs have emerged. These should be individually addressed between the patient and physician to partner in decision making ensuring the best outcomes for the patient and the fetus, as is the case for any drug. Physicians should also work closely with patients to assess the risks and benefits of psychopharmacotherapy and monitor for potential side effects, ensuring each patient receives individualized care. The American College of Obstetricians and Gynecologists (ACOG) Guidelines on Psychiatric Medication Use During Pregnancy and Lactation are widely used by physicians to treat perinatal and pregnant individuals, and it states, “Treatment with SSRIs or selective norepinephrine reuptake inhibitors during pregnancy should be individualized.”6 ACOGs guidelines also strongly recommend against withholding or discontinuing medications for mental health conditions due to pregnancy or lactation status alone.7 Psychiatric medications are safe, effective, and can be lifesaving if they are taken properly — as directed –under the care of an appropriately licensed healthcare professional.
The dissemination of inaccurate and unbalanced information by a federally sanctioned public panel has the potential to cause harm. It can undermine public confidence in mental health treatment, exacerbate stigma, and deter pregnant individuals from seeking necessary mental health care. We urge the FDA to review the composition and scientific rigor of its expert panels, particularly those influencing public health messaging. We also urge the FDA to re-evaluate the research that was presented to ensure that a true risk benefit analysis happens prior to any actions taken by the FDA.
The FDA has a duty to ensure that its public health guidance is rooted in science and transparency. As the largest organization worldwide for psychiatric physicians, we would like to partner with your agency to inform your policy decisions and to educate the public on the treatment of maternal mental health disorders. Many of our physician members have devoted their careers to exclusively taking care of women with maternal mental health conditions, often caring for thousands of patients a year, and are uniquely poised to provide you and your team accurate and balanced information. If we can be of further assistance, please contact Kristin Kroeger, Chief Advocacy, Policy, and Practice Advancement, at kkroeger@psych.org.
Sincerely,
Marketa Wills, MD, MBA, FAPA
CEO and Medical Director American Psychiatric Association
1 Davis, N. L., et al. (2019a). Pregnancy-Related Deaths: Data from 14 U.S. Maternal Mortality Review Committees, 2008- 2017. Atlanta, GA, Centers for Disease Control and Prevention, U.S. Department of Health and Human Services
2 American Psychiatric Association, Perinatal Mental Health Toolkit, 2023, https://www.psychiatry.org/psychiatrists/practice/professional-interests/women-s-mental-health/maternal-mental-health-toolkit
3 Clarke DE, De Faria L, Alpert JE, The Perinatal Mental Health Advisory Panel, The Perinatal Mental Health Research Team. Perinatal Mental and Substance Use Disorder: White Paper. Washington, DC: American Psychiatric Association; 2023 [Available from: https://www.psychiatry.org/maternal].
4 Clarke DE, De Faria L, Alpert JE, The Perinatal Mental Health Advisory Panel, The Perinatal Mental Health Research Team. Perinatal Mental and Substance Use Disorder: White Paper. Washington, DC: American Psychiatric Association; 2023, page 49 [Available from: https://www.psychiatry.org/maternal].
5 Clarke DE, De Faria L, Alpert JE, The Perinatal Mental Health Advisory Panel, The Perinatal Mental Health Research Team. Perinatal Mental and Substance Use Disorder: White Paper. Washington, DC: American Psychiatric Association; 2023, page 49 [Available from: https://www.psychiatry.org/maternal].
6 American College of Obstetricians and Gynecologists Guidelines on Psychiatric Medication Use During Pregnancy and Lactation, 2008, Am Fam Physician. 2008;78(6):772-778, found at: https://www.aafp.org/pubs/afp/issues/2008/0915/p772.html
7 American College of Obstetricians and Gynecologists Guidelines on Psychiatric Medication Use During Pregnancy and Lactation, 2008, Am Fam Physician. 2008;78(6):772-778, found at: https://www.aafp.org/pubs/afp/issues/2008/0915/p772.html
See American Psychiatric Association Request for Assistance
annie says
Lame Ducks – work with your physician, oh, and by the way, we produce the guidelines for physicians..
Moreover, recent meta-analyses have found no association between prenatal SSRI exposure and overall risk of birth defects.5 The analysis goes on to say that some concerns with specific SSRIs have emerged. These should be individually addressed between the patient and physician to partner in decision making ensuring the best outcomes for the patient and the fetus, as is the case for any drug. Physicians should also work closely with patients to assess the risks and benefits of psychopharmacotherapy and monitor for potential side effects, ensuring each patient receives individualized care. The American College of Obstetricians and Gynecologists (ACOG) Guidelines on Psychiatric Medication Use During Pregnancy and Lactation are widely used by physicians to treat perinatal and pregnant individuals, and it states, “Treatment with SSRIs or selective norepinephrine reuptake inhibitors during pregnancy should be individualized.”6 ACOGs guidelines also strongly recommend against withholding or discontinuing medications for mental health conditions due to pregnancy or lactation status alone.7 Psychiatric medications are safe, effective, and can be lifesaving if they are taken properly — as directed –under the care of an appropriately licensed healthcare professional.
My starting point was that it is in the public interest that clinical trials protocols are disclosed,’ says Dr Selley. ‘The logic of Pharma is, don’t let any information out at all in case something might cause us a problem in the future.’
The doctor who fought a quango for the truth about vaccine trials
https://www.conservativewoman.co.uk/the-doctor-who-fought-a-quango-for-the-truth-about-vaccine-trials/?utm_source=newsletter&utm_medium=email&utm_term=2025-09-18&utm_campaign=TCW+Daily+Email
DR PETER Selley, a retired general practitioner, has found a new pastime. He is taking the initiative in seeking more openness over vaccine clinical trials being run in the UK by Moderna, the company with which the Government entered into a strategic partnership in December 2022.
The object of his attention is the Health Research Authority (HRA), a Department of Health and Social Care (DHSC) quango tasked with making the UK ‘the easiest place in the world to do research that people can trust’.
Expanding the clinical trials network in the UK is a policy objective to which the Government is committed. On August 28, 2024, the Government announced it was investing up to £400million to create 18 clinical trial hubs to ‘fast-track the development of new medicines to patients’.
Health and Social Care Secretary Wes Streeting said: ‘It will enhance the UK’s global competitiveness and transform the country into the epicentre of health research, supporting an NHS fit for the future.’
HRA, which oversees the Research Ethics Service and regulates the conduct of clinical trials, is meant to promote transparency in research and protect the interests of participants by encouraging research that is safe and ethical. Twice over the last year Dr Selley has tested it over clinical trials run by Moderna and found it wanting.
The ten-year £1billion strategic partnership between the Government and Moderna was brokered by the Vaccine Taskforce before it was disbanded.
Since the partnership started at the end of 2022, Moderna initiated 13 clinical trials in the UK including trials for mRNA-1283, Moderna’s covid vaccine booster and mRNA-1345, its RSV (respiratory syncytial virus) vaccine.
The latter was the proxy used by the US National Institutes of Health under the prototype pathogen project to develop coronavirus vaccines during the gain-of-function moratorium when the FDA put a clinical hold on their development because of concerns that the vaccines caused damage to delicate lung tissues.
‘My starting point was that it is in the public interest that clinical trials protocols are disclosed,’ says Dr Selley. ‘The logic of Pharma is, don’t let any information out at all in case something might cause us a problem in the future.’
In principle Dr Selley has no concerns about trials of therapeutic products intended for cancer patients or other people who are ill. Vaccines, which are given to healthy people and carry the risk of making them less well, are another matter. Transparency over the trials enables closer independent scrutiny. One reason for this, he says, is that it is difficult to know who at the HRA has actual medical expertise.
On May 4, 2023, Moderna received Research Ethics Committee approval for the Next COVE trial of its covid booster vaccine, Spikevax mRNA-1283.
In December Dr Selley submitted a Freedom of Information request asking when the HRA received the request for approval of the trial, whether the Research Ethics Committee (REC) asked for any changes to the protocol and for the release of regulatory documents Moderna submitted including the investigator’s brochure, the clinical trial protocol and the animal safety studies.
The HRA partially answered the request, telling him that the submission was made on March 31, 2023, and that the REC requested no changes to the protocol. However citing commercial confidentiality, which HRA’s spokesman says it is obliged under the Freedom of Information Act to consider, it refused to release the documents.
The HRA said the investigator’s brochure contained unspecified trade secrets, and the clinical trial protocol contained ‘unpublished elements of the study design and regulatory strategy that are not publicly available and have significant commercial value’.
Dr Selley says: ‘My concern was that the HRA’s position would encourage pharmaceutical companies to intentionally and unnecessarily include commercially confidential information in these documents in order to prevent them being publicly released.’
He asked for an internal review and, dissatisfied with the response, escalated the matter to the Information Commissioner who asked HRA to identify to it the specific information that was commercially sensitive and explain how it would hurt either the interests of the HRA or the company. The HRA failed to respond.
Not wanting the gratuitous inclusion of commercially sensitive information to become routine practice in order to avoid public scrutiny of clinical trials, Dr Selley decided to take the matter to tribunal.
‘Moderna distributed the trial protocol to 200 different trial sites around the world. It would make no sense for them to include commercially sensitive information in a document that widely distributed because they wouldn’t want to risk their commercial interest in the trial,’ says Dr Selley.
In May 2025, a first tier information rights tribunal found in favour of Dr Selley in his case against the Information Commissioner acting on behalf of the HRA. The tribunal decision is a non-binding precedent, but it’s an important one. The tribunal found the HRA had failed to cite any specifics in defence of its argument.
A spokesperson for the HRA said: ‘As an organisation we champion transparency in health and social care research through our Make it Public campaign. We respect the outcome of the tribunal and will shortly be releasing the study protocol and investigator’s brochure for this study.’
Moderna was approached for comment on the precedent but offered none, saying that it wasn’t a party to the proceedings.
Plucky Duck..
David T Healy says
It’s good to see Peter S being recognized as a folk hero – what he has done is really quite extraordinary.
The SSRI and pregnancy matters have also brought Adam Urato more clearly into the frame as someone who has done extraordinary things.
Whether the efforts of one or two people can turn things around remains to be seen.
Are as Adam hopes the public starting to understand how all of this works? SSRIs, Tylenol, etc. They do alter fetal brain development but they are profitable. Is the public beginning to understand that the medical establishment will deny any problems and the corporate media will do the same?
If we keep bringing attention to these points will these meds eventually go the way of valproic acid in terms of the general acceptance that they cause harm.?
It took nearly 50 years for the harms of valproic acid to be accepted and comments on the Epidemiology of Autism Spectrum Disorder post brings home, we still have groups linked to pharma busily minimizing the effects of even valproic acid.
David
chris says
Was watching this the other week, interested by her patients saying they didn’t want SSRI’S.
Breaking the Silence: Why PMDD Needs More Attention? | With Dr Milli Raizada
https://m.youtube.com/watch?v=pYcHUkcsga0&pp=0gcJCRsBo7VqN5tD
annie says
APA Statement on White House Announcement on Autism
September 22, 2025
https://www.psychiatry.org/News-room/News-Releases/APA-Statement-on-White-House-Announcement-on-Autis
Washington, D.C. — In reaction to today’s White House announcement, the American Psychiatric Association issued the following statement:
“It is essential that the administration prioritizes evidence-based support for individuals on the autism spectrum and invests in long-term comprehensive research about the disorder.
Vaccines do not cause autism. Claims of any such association have been repeatedly discredited in peer reviewed studies.
Autism is a complex disorder, and it is incorrect to imply that a handful of studies have established causation. A strong base of evidence shows that acetaminophen, when taken as directed, is safe for use during pregnancy. Any decisions around a course of treatment should be determined by a patient and their doctor.
Leucovorin (folinic acid) has not been a recommended treatment for autism. It will require many more years of research before we know if leucovorin is an appropriate treatment for individuals with autism.
Autism spectrum disorders exist on a spectrum of neurodiversity. The country must focus its resources on expanding access to care and to building the evidence-base for future treatments.”
American Psychiatric Association
The American Psychiatric Association, founded in 1844, is the oldest medical association in the country. The APA is also the largest psychiatric association in the world with more than 39,200 physician members specializing in the diagnosis, treatment, prevention, and research of mental illnesses. APA’s vision is to ensure access to quality psychiatric diagnosis and treatment. For more information, please visit www.psychiatry.org.
Secretary Kennedy@SecKennedy7h
Today the @US_FDA will issue a physician’s notice about the risks of acetaminophen during pregnancy and begin the process to initiate a safety label change.
Secretary Kennedy@SecKennedy8h
We promise transparency as we uncover the potential causes and treatments of autism, and we will notify the public regularly of our progress.
Peter Selley says
High-quality care is about more than safety alone.
That’s what they believe at the UK’s version of the FDA, the MHRA.
Dr June Raine has stepped down as CEO and has been replaced by a true bureaucrat, Lawrence Tallon, who has got his claws into identifying MHRA’s priorities.
https://www.gov.uk/government/news/looking-to-our-future-reflections-on-the-strategic-choices-ahead-for-the-mhra
“Our central role is to protect patient safety, and that will always be the cornerstone of the agency; but we know that high-quality care is about more than safety alone. It’s also about effectiveness, timeliness, experience; and increasingly, about empowering patients to make informed choices within what we are thinking of as the “preference zone””.
This is the buzz expression for patient choice after discussion with their healthcare professional.
Pharma have recognised this for a long time –
Q “Is it safe for me to take acetaminophen/paracetamol/antidepressants while pregnant?”
A “You should discuss this with your doctor”
Dr. David Healy says
That’s a fabulous new Buzzword
Plays straight into the forthcoming Reno event
It used to be called Shared Decision Making but they never meant shared equally – it was always informing your consent so you would do as your doctor told you
David
annie says
Crafted advice, shades of SSRI advice, six times, talk to your healthcare professional/health provider/ask a doctor
https://www.tylenol.com/frequently-asked-questions#concerned-about-acetaminophen-and-autism
We understand the recent media coverage you’re reading may cause concern or lead to questions. We want to make sure you have the answers.
Here is what we can tell you:
Credible, independent scientific data continues to show no proven link between taking acetaminophen and autism.
Medical and public health organizations agree.
This includes:
American College of Obstetricians and Gynecologists
Society for Maternal-Fetal Medicine
Autism Science Foundation
American Academy of Pediatrics
Our best advice? Talk to your healthcare professional before taking or administering acetaminophen.
As our label says, ‘If pregnant or breast-feeding, talk to your healthcare professional before use.’
Your health provider is best positioned to advise whether taking this medication is appropriate based on your unique medical condition.
If you are treating your little one with acetaminophen, please know that there is no credible science that shows taking acetaminophen causes autism. When searching what medicine may be suitable for infants and children, the best thing you can do is to speak with your healthcare provider — they will guide you on what is best for your child’s pain and fever. Be sure to always follow the dosage guidelines provided on the product label or by your healthcare provider.[1,2] For Infants’ TYLENOL® in particular, you will need to ask a doctor for dosing information if your child is under 2 years of age.
annie says
Wendy Burn CBE (She/her) reposted
Neil Stone @DrNeilStone Sep 24
This is what a REAL scientific breakthough looks like
Not that Tylenol stuff
Kemi Badenoch@KemiBadenoch
This is irresponsible conspiracy-theory nonsense. It will create fear and anxiety among parents and pregnant women will suffer unnecessary pain by believing it.
Buzzfeed
So, Robert De Niro was on Jimmy Kimmel’s “comeback” show on Tuesday, and his one-liner about it is going viral.
After going off on the FCC chairperson, De Niro made his exit by pretending to get a phone call from the President, “Hi, handsome, I mean Mr. President, okay, okay. You got it, sir.” Then he said to Jimmy, “Look, I gotta go. A couple cases of Tylenol fell off a truck, and now I gotta figure out how to put autism in them.”
TYLENOL®@tylenol
We actually don’t recommend using any of our products while pregnant. Thank you for taking the time to voice your concerns today
7:31 PM · Mar 7, 2017
TYLENOL®@tylenol
Congrats on your upcoming addition! SO exciting! It’d be great to touch base real quick since we haven’t tested Tylenol to be used during pregnancy (and see what coupons we have for baby!) Call us when you can at 1-877-895-3665, M-F from 9a-5:30pm ET w/ your Twitter handle
5:03 PM · Jun 17, 2019
A Psychiatrist, a Politician and an Entertainer
Doing the rounds, somebody kept the receipts..
Harriet Vogt says
I’ve been so fascinated by the content of the ‘Donny and Bobby Show’ – that I realised I’ve missed the point – its purpose.
Nothing to do with communicating science – it’s purpose was simply a statement of power and ownership wasn’t it? Saying to industry and vested interests – we own this space now, we own the science (viz the ‘backing group’), we make the decisions, suck it up. And ofc they didn’t discuss the actual science – since that would suggest that it was debatable.
Thinking about Farrage and his ‘deployment’ of Aseem Malhotra at the Reform conference in the UK – similar political purpose. The whole positioning of Reform is to challenge failing establishment politics. Farrage has been openly critical of overdiagnosis – and ofc got it in the neck from the ‘compassionate’ left . Reform’s health policies are primarily business thinking – that’s what Farrage is about – but I noticed they’ve tucked in vaccine related excess deaths. Imo Malhotra is good on nutrition and coronary health (I liked ‘The Pioppi Diet’ a lot) – right to flagship vaccine harms, but in my ignorant opinion, simplistic. Apparently he contributed to Reform’s health policy. What Reform need is a proper medical grown up.
annie says
Don’t go after the ‘Good ‘uns’
Dr Aseem Malhotra reposted
Dr Aseem Malhotra@DrAseemMalhotra
For the avoidance of doubt and to stop repeated media errors being amplified including that of the Prime Minister I am not a ‘health advisor’ to Reform. I never have been and I have not been involved in helping them write their health policy. I’m not even a member of @reformparty_uk or any political party. I do that deliberately because it keeps my voice as a healthcare practitioner and public health advocate independent. That also applies to my advisory role to MAHA Action. I share my views and get feedback ( written and verbal ) on a regular basis with senior advisors within HHS, senior scientists within NIH and members of ACIP. At no point have they told me to ‘shut up’ or tried to influence my advocacy even if they disagree.
As to Reform, I was invited to share my insights including that of the US administration in reference to MAHA by Nigel Farage as a guest speaker at their conference. Again I must emphasise that I’m not an ‘anti – vaxxer’ which is in my view a term of abuse and deliberately used to smear and stifle ANY discussion on vaccine safety which is counterproductive. I have written and continue to reiterate in my interviews that in my view traditional childhood vaccines are the safest of all medical products which I also stated in early 2021 on @GMB when I was asked to help tackle covid vaccine hesitancy for high risk individuals of BAME background. YES, let me repeat I took two doses of Pfizer and supported and encouraged it’s use for elderly and high risk on national television. Of course the evidence has greatly evolved since then on the covid mRNA product both in relation to its safety and effectiveness as I stated in my reform speech. In the spirit of openness I have also been diagnosed with covid vaccine injury as I told @megynkelly and have been managing and supporting patients with covid vaccine injury.
I’m ALSO greatly concerned as I warned in 2022 when I called for a moratorium on the covid ‘vaccine’ ( more appropriately described as a gene therapy) that because of mishandling of the pandemic especially through coercion and mandates ( with lack of accountability) trust in other vital vaccines has declined. Large sections of the media have also tried to deliberately isolate me despite the fact that THOUSANDS of doctors share my views evidence by the Hope accord petition. Also in reference to the Royal Family and a covid vaccine cancer link that was something I was asked to convey by one of the worlds most published and eminent oncologists, Professor Angus Dalgleish. He is more than happy to give interviews to explain his position further. Please do that and challenge him with whichever expert you like. I’m sure he will welcome it.
To reach a greater scientific truth for a healthy society it is essential that we listen to all perspectives through open and respectful dialogue and not suppress or smear legitimate voices and concerns. We’ve already experienced the damage that has done throughout the pandemic. Let’s all do better
8:02 AM · Sep 25, 2025
·
55.5K Views
Harriet Vogt says
It’s not a question of going after the ‘good ‘uns’. It’s a question of trying to understand how they are being used by political parties – in a week when politicians seem to be running amok over acetaminophen.
Dr David Bull, Chairman Reform, media glitterati and former doctor, definitely introduced AM as – ‘Now I know this chap because he worked with me to write Reform UK’s health policy…’
AM definitely said, ‘One of Britain’s most eminent oncologists Professor Angus Dalgleish said to me to share with you today that he thinks it’s highly likely that the Covid vaccines have been a significant factor in the cancers in the royal family’. Which I think is highly speculative – to say the least.
After this blooper, pounced on by Free Gear Keir – all concerned are quick to deny AM’s involvement in the writing of Reform’s Health Policy – including AM himself.
But was his purpose to symbolise a party questioning establishment views?. How significant does he really believe the vaccine – cancer links are – how much was it a bit of outrage to make sure he hit the headlines.. And another banderilla in the side of the medical establishment who are whining to the GMC again?
In a week when, with zero knowledge of the evidence re APAP/paracetamol risks, politicians from Obama to Streeting, arguably the sublime to the ridiculous, have sneered at the ‘Trump APAP Show’, only one hasn’t -Farage:
‘Speaking to Nick Ferrari on LBC this morning [24 September], Farage refused to criticise President Trump’s claims.When asked if he agreed with Trump on a link between paracetamol and autism, he said: “I have no idea, We were told thalidomide was a very safe drug and it isn’t. Who knows. I don’t know, you don’t know.When it comes to science I don’t side with anybody. It’s never settled. We should remember that.’
https://politicsuk.com/farage-backs-trump-paracetamol-conspiracy
annie says
God knows, Harriet, there has been enough political posturing, over all things ‘medical’ during Covid and beyond.
Political parties will always spin things to their advantage, and Reform is no different.
I have followed Dr. Aseem Malhotra from the early days, his First Do No Pharm film in Leicester Square was a triumph. The extraordinary energy with which Dr. Malhotra has conducted himself has resulted in him being a trusted UK ally in the Trump and Kennedy administration.
Seriously interested parties might like to listen to Dr. Malhotra in this ‘Right of Reply’
https://www.youtube.com/watch?v=1XGLD0xg9sY
Harriet Vogt says
Take several calming breaths before reading this Guardian interview with Barack Obama:
https://www.theguardian.com/us-news/2025/sep/24/obama-says-trump-linking-paracetamol-to-autism-is-violence-against-the-truth
‘We have the spectacle of my successor in the Oval Office making broad claims around certain drugs and autism that have been continuously disproved,” he said. “It undermines public health … that can do harm to women.”
Absolute b/s. Proof that politicising medicine is what harms women.
The debate has become a power fashion parade – divorced from the safety of women and the unborn child.
Peter Selley says
X marks the spot.
https://x.com/MHRAgovuk/status/1970506529125064995
If this is in your preference zone, speak to your midwife, GP or pharmacist if you have any concerns.
Harriet Vogt says
Interesting developments.
Ann Bauer, in an interview with ABC epitomised ethical science and the precautionary principle herself:
‘She welcomed the White House’s motion to consider labelling Tylenol to emphasize judicious use of the drug but worries about how the MAHA movement might distort a careful message. On Sept. 2, the right-wing news outlet One America News Network posted an interview with newly appointed CDC vaccine adviser Robert Malone, writing that Malone “speculates RFK Jr. may have an important announcement this month regarding a potential link between Tylenol, multiple vaccinations and autism in children.”
I was sick to my stomach,” Bauer said, concerned that Kennedy would link her study to discredited theories, causing doctors and scientists to reject her far more measured work
Bauer, an epidemiologist at the University of Massachusetts-Lowell, & her team called for more judicious use of the drug until the science is settled…I would not take his funding because it could take away from the credibility of my study in the same way that taking money from pharmaceutical companies does.”
https://abcnews.go.com/Health/sick-stomach-trump-distorts-facts-autism-tylenol-vaccines/story?id=125852331
Later on this evening, she posted on X, the actual letter the FDA sent to doctors – and it is effectively the precautionary principle in action.
Notice to Physicians on the Use of Acetaminophen During Pregnancy
In recent years, evidence has accumulated suggesting that the use of acetaminophen by pregnant women may be associated with an increased risk of neurological conditions such as autism and ADHD in children. Some studies have described that the risk may be most pronounced when acetaminophen is taken chronically throughout pregnancy to childbirth. These concerns may be magnified by the fact that a very young child’s liver may still be developing and thus a child’s ability to metabolize the drug may be limited.
To be clear, while an association between acetaminophen and autism has been described in many studies, a causal relationship has not been established and there are contrary studies in the scientific literature. The association is an ongoing area of scientific debate and clinicians should be aware of the issue in their clinical decision-making, especially given that most short-term fevers in pregnant women and young children do not require medication.
In the spirit of patient safety and prudent medicine, clinicians should consider minimizing the use of acetaminophen during pregnancy for routine low-grade fevers. This consideration should also be balanced with the fact that acetaminophen is the safest over-the-counter alternative in pregnancy among all analgesics and antipyretics; aspirin and ibuprofen have well-documented adverse impacts on the fetus.
Sincerely,
Martin A. Makary, MD, MPH
Commissioner of Food and Drugs
https://www.medpagetoday.com/washington-watch/fdageneral/117617
It’s interesting to reflect on the whole performance as communications’ strategy. If Trump and RFKJr hadn’t done the power fandango upfront and caused a media riot about Tylenol, would anyone have paid any attention to the measured message delivered by the FDA? Quite possibly not. Will this measured message change the minds and behaviour of pregnant women and doctors? That remains to be seen.
annie says
Tylenol maker Kenvue is reeling after unsupported claims that its popular drug causes autism. Kennedy is unlikely to stop there.
Tylenol may be only the beginning.
https://www.forbes.com/sites/alexknapp/2025/09/26/rfk-jr-is-targeting-vaccines-and-tylenol-are-prozac-and-ozempic-next/
“Another big target: antidepressants. During Kennedy’s confirmation hearings, he falsely claimed that people have a harder time stopping the use of serotonin-based antidepressants “than people have getting off of heroin.” He’s also made the unfounded claim that teenagers who use them are more likely to commit school shootings (they aren’t.)
One of the goals of Kennedy’s “Make America Healthy Again” movement is to “assess the prevalence of and threat posed by the prescription of selective serotonin reuptake inhibitors.” Any restrictions on them would be a grave concern to the approximately 11% of the population that uses them to treat depression, anxiety and other issues.”
And that is Forbes unequivocal entry in to the antidepressant market.
If he had done his research he would have discovered that Robert is alive on this.
RFK Jr. “We’re launching studies on the potential contribution of some of the SSRI drugs and some of the other psychiatric drugs that might be contributing to violence.”
Yet another piece of despotic journalism, which probably took him five minutes to write.
annie says
How does a Dad, deal with this?
https://x.com/VoiceStephen/status/1971315986490937811
chris says
Just wish to add to this ongoing tragedy for people who don’t know. John Virapen was mostly responsible for Prozac at 7mins in he informs the audience they knew from the trials the drug was causing suicide ideation.
https://www.youtube.com/watch?v=9Eet4x5_8tE
John’s horrific legacy continues for how much longer…..
Dr. David Healy says
Chris
The Virapen stuff never worked. It may be here that the translation is getting in the way. It may be he was trying to persuade Swedish and German audiences who have a long tradition of believing their government and are not going to be persuaded by this. But it’s partly also that there was always something not right about what he said – or at least something that didn’t work.
David
chris says
This situation of moving people to extreme politics and casting politicians as card board cut out puppets blarting obvious nonsense reminds me of a quote in Father, Son and CIA by psychiatrist Harvey Weinstein
Ewen Cameron’s presidential address to the American Psychiatric Association in 1953 suggests his involvement in the Cold War and his concerns about communism. Although he also used the opportunity to express his concerns about McCarthyism, Cameron held to a now familiar position – our best hope for a new world order and without hysteria, one without the totalitarianism of either the right or left, lies in science. With behavioral scientists as leaders, order would emerge from chaos.
“our best hope for a new world order and without hysteria, one without the totalitarianism of either the right or left, lies in science. With behavioral scientists as leaders, order would emerge from chaos. ”
I’d be laughing it things were not so serious. The price of gold is now so high gold jewellery is not being bought by the public, but the price is still going up, it’s being bought by powerful entities such as central banks, hedge funds, crypto people who want backing. Gold is the go to backstop when fear of a financial crash infects everyone’s brains. It’s also a sigh of inflation not being controlled. Gold is climbing a wall of terror.
Anyone fancy behavioral scientists as leaders ?
Dr. David Healy says
Chris
This is very perceptive and contains an extraordinary irony – Harvey Weinstein. There is Harvey Weinstein who seems to have had no middle name and is infamous but before him there was a highly thought of psychiatrist called Harvey M Weinstein who is celebrated for researching into how communities rebuild after wars or other disasters. Worth googling https://humanrights.berkeley.edu/people/harvey-m-weinstein/
Weinstein’s work points to something in the human spirit that appears to be beyond the ken of behavioral science. It would be great if we could mobilize it to avoid disasters rather than just depend on it to rebuild afterwards.
David
annie says
When Thomas Kingston, a member of the Royal Family, fatally hot himself, his wife, Gabriella, took on board, the view of the Expert Witness, in the case, David Healy. This was a high profile case that could have set the world alight. The case determined that Thomas shot himself due to the resultant use of two SSRIs, one after the other, when the first was detrimental. His doctor did not ascribe due diligence.
The media flip-flopped, he had money worries.
None of the Royal Family supported Gabriella publicly about this. Neither did Psychiatric Associations.
If Robert Kennedy’s future investigations in to SSRIs and violence bear fruit, and I don’t see at all why they shouldn’t, then horrible tragedies like Dexter and Romain’s would not have happened.
The whole APA/RCP/GP apparatus is damage control.
All the harmed, injured and dead, will not see in their lifetime, the President of the US, balling his feelings or Robert Kennedy getting his grip. So many complain that nothing happens, so when a shouter and a mover start their investigations, it should not be beyond the wit of most people to get behind them.
If they do a great job, it could rip apart all the prejudices, Pharma antics, and restore medicine to that for which it was designed for.
chris says
I can report a cautious success. Last week I learned of an aunt who had been put on Cymbalta and had a serious reaction; she was in hospital normal one and been told she was very low on sodium, delirious, confused and to stay on the Cymbalta because it takes a few weeks to kick in.
I immediately messaged the relatives to look up the medication on rxisk for correlations to the adverse reaction and maybe contact DH. Unlike my other relative the response was positive; they immediately realised it was the drug and keeping her on it was going to be a terrible mistake. At 90 my relative is certainly in the danger zone, still in hospital but sounding better; not so confused and able to slowly answer questions correctly.
Was it the case that Kennedys wife ended her life on psych drugs. Did he realise at the time she probably had akathisia, or it was after, is this in part what motivates him I wonder ?
Dr. David Healy says
You’ve raised an intriguing point. I wonder can we find out anything more
D